Measurement system for an analyte determination and a method

ABSTRACT

A measurement system and method for operating a measurement system is disclosed for an analyte determination. The system includes an analysis unit, which is configured to determine a measured analyte value for a body fluid specimen that is applied, a fingerprint sensor, which is configured to detect fingerprint sensor signals for one or various users, and a control unit, which is connected to the analysis unit and the fingerprint sensor unit for data transmission. The control unit is configured to perform a user identification using the detected fingerprint sensor signals and after successful user identification to enable a determination of a measured analyte value with the analysis unit for an identified user. The control unit is additionally configured to analyze the detected fingerprint sensor signals and optionally additional detected fingerprint sensor signals in addition to the user identification in order to provide control signals for performing additional measurement system functions.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 13/094,141 filed Apr. 26, 2011, which claims priority toEuropean Patent Application No. 10004640.8 filed on May 3, 2010, whichis incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to a measurement system for an analytedetermination, in particular for a blood glucose determination, as wellas a method for operating a measurement system for the analytedetermination.

BACKGROUND

Analyte measurement systems are intended to be used by one or more usersto assay an analyte measured value, for example, the blood glucosevalue, based on analysis of a body fluid specimen, in particular aspecimen of urine, saliva, serum, plasma or blood from the respectiveuser. For this purpose, the measurement systems have an analysis devicefor experimentally analyzing the blood specimen to thereby ascertain ameasured value for the blood glucose. The measurement systems usuallyhave a control unit equipped with hardware and software components tocontrol the operation of the measurement system, in particular also as afunction of the detected inputs by the user who enters these values viaone or more user interfaces of the measurement system. The measurementsystems for the blood glucose assay are usually designed as handhelddevices.

A portable glucose meter for assaying the blood glucose value of a bloodspecimen, which is configured for remote data transmission, is knownfrom the document US 2009/0138207 A1. The known glucose meter has apatient identification unit, which may be designed with a biometricsensor, for example. A similar device is also described in the documentUS 2007/0231209 A1.

The document US 2009/0010804 A1 discloses an analysis device foranalyzing a blood specimen, for example, which in one embodiment isprovided with user identification based on fingerprint testing. A methodof fingerprint verification is also known from the documents U.S. Pat.No. 7,116,805 and U.S. Pat. No. 7,009,497.

The document US 2007/0016104 A1 relates to a glucose meter, which in oneembodiment performs a user identification with the help of analysis of afingerprint. The glucose meter has an analysis device for analyzingblood specimens and a user identification method integrated into theanalysis device. In operation of the glucose meter after successful useridentification, operating parameters are adjusted according to theoperating parameters allocated to the recognized user. The glucose metermay be used by multiple users, which is why it is a multi-userembodiment. By performing user identification, unauthorized persons areexcluded from using the glucose meter.

SUMMARY

An improved measurement system is disclosed herein for analytedetermination and a method for operating the measurement system, bywhich individual use of the measurement system is achieved by one ormore persons and the efficiency thereof is improved, while operatingconvenience is optimized on the whole.

According to one aspect, a measurement system for analyte determination,in particular blood glucose determination, is disclosed that has ananalysis device, which is configured to determine an analyte measuredvalue, in particular a measured value for the blood glucose, for a givenbody fluid specimen, for example, a blood specimen, a fingerprint sensordevice, which is configured to detect fingerprint sensor signals for oneor multiple users, and a control device, which is connected to theanalysis device for data transmission, and the fingerprint sensordevice, such that the control device is configured to perform a useridentification using the detected fingerprint sensor signals, and aftersuccessful user identification, to enable an assay of an analytemeasured value using the analysis device for an identified user, andsuch that the control device is also configured to optionally alsoanalyze additional detected fingerprint sensor signals in addition tothe user identification in order to provide control signals forexecuting additional measurement system functions.

According to another aspect, a method for operating a measurement systemfor analyte determination, in particular for blood glucose determinationis formed in a single or multi-user embodiment in which a fingerprintsensor device and an analysis device equipped for determination of ananalyte measured value are connected to a control unit at least for datatransmission, such that the method comprises the following steps:detection of fingerprint sensor signals by means of the fingerprintsensor unit, evaluating the detected fingerprint sensor signals by thecontrol unit to identify a user, enabling an assay of an analytemeasured value for a body fluid specimen to be fed into the unit usingthe analysis unit in successful user identification and providingcontrol signals for execution of additional measurement system functionsin that the detected fingerprint sensor signals and optionally otherdetected fingerprint sensor signals are additionally analyzed by meansof the sensor unit in addition to the user identification.

The measurement systems and methods disclosed herein have the advantagein comparison with the prior art in that individualized use of themeasurement system is made possible for the user in a simple andconvenient manner, namely by touching the fingerprint sensor. Inaddition to the user identification that has been provided, thefingerprint sensor signals are analyzed by the control unit in order tobe able to derive control signals, with which additional functions ofthe measurement system can be utilized. The fingerprint sensor signalsare analyzed in a type of second use, i.e., in addition to theiranalysis in conjunction with the user identification. The supplementaryanalysis of the fingerprint sensor signals and providing the controlsignals are preferably performed after successful user identificationindependently of taking into account the electronic information. Thismay mean that the control signals are generated independently ofuser-specific information. Alternatively, it is also possible to providefor user-specific information to be taken into account in deriving thecontrol signals in conjunction with the supplementary analysis of thefingerprint sensor signals, for example, with regard to specialmeasurement system functions, which are stored or blocked in aretrievable manner by the control unit for a user in the measurementsystem.

In the supplementary analysis, the fingerprint sensor signals used foruser identification may be analyzed entirely or partially. It mayoptionally be provided that additional fingerprint sensor signals aredetected with the fingerprint sensor device.

One embodiment may provide that the measurement system is formed with asample taking unit. One embodiment comprises a puncture unit forpuncturing the skin for taking a blood specimen.

With the help of the user identification on the basis of the fingerprintsensor signals the measurement system can be designed as a multi-userembodiment.

According to another embodiment, the control unit is also configured toprovide analyte measured values, in particular blood glucose values,which are determined with the help of the analysis unit for the bodyfluid specimen applied, in particular a blood specimen, after asuccessful user identification, data storage and/or output allocated toan identified user. The analyte measured values determined for anidentified user are supplied for data storage and/or output in such away that they are recognizably allocated to the identified user. Forexample, the data record allocated to a user is provided with anidentifier which identifies the users. In conjunction with the datastorage, it may be provided that a summary of memory areas assignedindividually to different users is kept in the control unit. The analytemeasured values assigned to an identified user are then stored in therespective memory area and can be read out there again.

In yet another embodiment, it is envisaged that the control unit is alsoconfigured to provide control signals for controlling a user menu and tocontrol the user menu in accordance with the control signals in thesupplementary analysis of the detected fingerprint sensor signals as afunction of the detected fingerprint sensor signals. The user menu isdisplayed, for example, on a display screen integrated into themeasurement system. The fingerprint sensor signals in this embodimentmay be analyzed so that the user's navigation in the displayed user menuis detected. In one embodiment, the fingerprint sensor unit is thereforeembodied as a type of trackball or trackpad device. In this way, it canalso provide the user in particular with the option of definingoperating parameters for operation of the measurement system in assay ofthe analyte measured value by means of the fingerprint sensor unit.

Another embodiment provides for the control unit to additionally beconfigured to identify a finger of a human hand in the supplementaryanalysis of the detected fingerprint sensor signals and to providecontrol signals assigned to this finger as a function of the identifiedfinger. According to this embodiment, control signals assigned to theoperating functions of the measurement system are generated as afunction of the finger recognized. For example, it is possible toprovide for the “ready-for-measurement mode” function to be triggered onrecognition of the user's index finger. However, if the user's middlefinger is detected, this means, for example, that the measurement systemis blocked for further use so a mode such as “end of this use” istriggered. The measurement and the respective data storage are thenterminated. Electronic information about the functions assigned to thevarious fingers is stored in the measurement system, so that thecorresponding control signals can be generated on recognition of acertain finger of the hand. The finger-specific determination may beperformed on a user-specific basis or independently of certain users.

According to a further embodiment, the control unit is also configuredso that in the supplementary analysis of the detected fingerprint sensorsignals, a finger tissue analysis is performed, and control signals foruser information are provided as a function thereof.

In still a further embodiment, the measurement system further comprisesan input unit configured to receive a code key, wherein the control unitis further configured to additionally analyze the received code key, toenable the determination of the analyte measured value and/or to providethe control signals for executing the additional measurement systemfunctions. In this case a combined use of finger print identificationand one or more code keys is possible. The code keys may also bereferred to as security key in general. Such device is preferably usedin a multi-mode or multi-role environment. For example, a physician mustbe authorized to access the system, he is then allowed to select apreinstalled protocol or mode of operation and give permission to aselected patient to collect data using this protocol. Thereby, steps ofoperation for reporting and using the results of the analysis of thesedata may be limited to the physician and the patient. As an option,after some anonymisation a meta-analysis may be allowed for a researchperson, or an overview analysis is done by a physician for all of hispatients. In one embodiment, it is proposed to use a fingerprint sensorunit on a data collection device and rule sets in the software of thecollection device and in an optional PC- or Server-Software useful tohandle the collected date together with one or more code keys.Additional incorporation of a fingerprint sensor in an optionalcommunication device used to ease data transfer and data managementmight give additional advantage. Such hardware configuration can be usedin different use cases: on a single device a physician can log-in andthen prepare this device for the patient; alternatively, a device usedby the physician is coupled or paired with another device. This seconddevice is then prepared to be handed over to the patient for datacollection. The so-called physician device may be not a collectiondevice, but may be a coupled communication device like a PC or acommunication link device like Accu-Chek® S artPix, but it comprises afingerprint sensor.

The code key based access method may be used to organize levels ofaccess rights that are needed to organize such a multi-mode/multi-usersystem. In one embodiment, the system is opened up by a secure or codekey, then the fingerprint sensor unit is activated. In all followingoccurrences of a needed key input, the fingerprint sensor unit is usedinstead of typing in a long code sequence.

In a multi-mode system there is a need for a whole set of “keys”. Thefingerprint signals of different fingers may be used to activatedifferent modes of operation in the system. For example, afteractivating by input of a number code a physician scans his fingers, theimage of the index finger will be used to pass on his activation to apatient for a special protocol. Thereby this patient receives rights touse the measurement device for this operation protocol. The physiciancan activate an editing function for protocols on the collection device,if he wants to change some conditions of a protocol to tailor it to aspecial patient, then his special protocol can be associated to aspecial patient.

In conjunction with the embodiments of the invention for operating ameasurement system for determination of an analyte, in particular for ablood glucose determination, the explanations given in conjunction withthe respective embodiments of the measurement system are applicableaccordingly.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is explained in greater detail below on the basis ofexemplary embodiments with reference to the figures.

FIG. 1 is a schematic diagram of a measurement system for analytedetermination in a multi-user embodiment, and

FIG. 2 shows schematically a sequence in operation of the measurementsystem from FIG. 1.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation on the scope of theinvention is intended. Any alterations and further modifications in theillustrated devices and described methods and further applications ofthe principles of the invention as disclosed herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates.

Although an exemplary embodiment is described below on the basis of ameasurement system for blood glucose determinations from bloodspecimens, the invention is not limited to this. The proposedtechnologies may also be used for other substances and parameters to bedetected and for other specimen fluids such as serum, plasma, urine,saliva or the like, which are referred to jointly here as “analytes”.Additional analytes in the sense understood here include not onlyglucose but also in particular lactate, cholesterol, triglycerides,coagulation parameters, such as the prothrombin time (Quick value) andthe like.

The measurement system may connect to a server device from whichelectronic data may be received. The electronic data may belong to anyoperation aspect of the measurement device. Different sets of electronicdata received from the server device may be applied depending on theresult of key and/or finger print analysis.

FIG. 1 shows a schematic diagram of a measurement system for bloodglucose determination in a multi-user embodiment, i.e., in a deviceembodiment, allowing use by one person or preferably multiple differentpersons. The measurement system is therefore equipped with hardware andsoftware components as explained in more detail below.

In this measurement system, a control unit 1 is connected to an analysisunit 2 for data transmission. With the help of the analysis unit 2, aspecimen of blood taken from a user can be analyzed with regard to theblood glucose value in particular. Such a use of the measurement systemby one or more users is possible only if the user is first recognized aspart of a user identification. For the user identification, themeasurement system has a fingerprint sensor unit 3 coupled to thecontrol unit I. Each user is identified by placing one or more fingerson the fingerprint sensor unit 3. The identification is successful if,on the basis of electronic data stored in the measurement system on theone hand and the analysis of the detected fingerprint sensor signals onthe other hand, the control until 1 ascertains that the fingerprintsensor signals can be assigned to an authorized user. After successfuluser identification in this way, the measurement system is released foranalysis of a blood specimen by analysis unit 2.

The blood glucose values determined as part of the analysis are storedin a memory unit 4 in a user-allocated manner and/or are made availablefor data output via a data output interface 5, whether for a hardwireddata output or a wireless data output. In addition or alternatively, themeasured values may be displayed on a display 6. The blood glucosevalues determined are assigned to the identified user, for example, byproviding an identifier for the user to accompany the data record withthe measured values for the blood glucose.

In the embodiment shown in FIG. 1, the measurement system also has asample taking unit 7, which is configured to enable the user to obtain ablood specimen after successful user identification. The blood specimentaken is then transferred to the analysis unit 2 and analyzed therealong a capillary system, for example.

If another embodiment involves a measurement system for determininganother analyte in a body fluid specimen, then the analysis unit 2 andthe sample taking unit 7 in particular are designed accordingly.Analysis units and sample taking units are known as such in variousembodiments, therefore no further explanation is required here.

The measurement system may optionally have one or more additional devicecomponents 8, which is indicated by dashed lines in FIG. 1. For example,an input unit may be provided, the input unit being configured toreceive one or more code keys. In a preferred embodiment, the code keyis received in response to a user input.

The control unit 1 is also configured to analyze the detectedfingerprint sensor signals via the fingerprint sensor device 3 beyonduser identification to supply control signals for other operatingfunctions of the measurement system. This includes, for example,deriving control signals for a user interface formed with the display 6and coupled to the control unit 1 for data transmission. For example,the user can in this way navigate in a graphical user menu and mayselect functionalities by means of the fingerprint sensor unit 3. Inthis case, the fingerprint sensor unit 3 is embodied as a type oftrackpad device, for example.

Alternatively or additionally, the further analysis of the fingerprintsensor signals with the help of the control unit 1 may provide thatcontrol signals are generated as a function of the type of fingerrecognized so that, for example, first control signals are generatedwhen the index finger is recognized, whereas second control signals aresupplied when another finger on the user's hand is recognized in asupplementary analysis of the fingerprint sensor signals. In this case,the control unit 1 has electronic information, which is assigned certainoperating functions of the measurement system as a function of the typeof finger. Therefore, electronic information for an assignment betweenthe type of finger on the one hand and the operating functionality ofthe measurement system on the other hand is stored in memory unit 4, forexample.

As an alternative or in addition, code key analysis may be used foridentifying different users and/or modes of operation assigned todifferent users. For example, first a master user, e.g. a physician, maybe identified by the finger print sensor device 3. After identificationof the master user the measurement system is cleared for operation ingeneral. Following, a specific user may identify itself by a code key.Code key identification may clear the measurement device for thedetermination of a certain analyte.

In additional or alternatively, the control unit 1 is configured toperform a finger tissue analysis in the more extensive analysis of thedetected fingerprint sensor signals and to derive control signals as afunction thereof for the measurement system. Thus the supplementaryanalysis of the fingerprint sensor signals may reveal extensive scarringof the tissue of the finger for which the sensor signals have beendetected, which may be the result of frequent blood sampling on thisfinger. If in the supplementary analysis of the fingerprint sensorsignals, such a circumstance is recognized by the control unit, controlsignals are generated, notifying the user by way of the display 6 thatit is advisable to take the blood specimen from another finger.Supplementary or alternative optical signaling in the form of a coloredlamp may also be provided, depending on the result of the finger tissueanalysis. Thus, a red control display could signal to the user of themeasurement system that the finger initially placed on the fingerprintsensor unit 3 is not suitable for taking a blood specimen.

In summary, FIG. 2 shows a flowchart for operation of the measurementsystem from FIG. 1 in an exemplary embodiment. First, useridentification is performed in a step 20. If user identification issuccessful, then in step 21 the measurement system is enabled for use bythe identified user. Then in step 22 the detected fingerprint sensorsignals and/or optionally any fingerprint sensor signals additionallydetected beyond the user identification are analyzed to derive controlsignals for additional measurement system functions. This may be donebefore, during and/or after blood specimen has been analyzed. Accordingto FIG. 2, a blood specimen is then analyzed in step 23 in the selectedexemplary embodiment. Next in step 24, the measured blood glucose valuesthereby obtained are supplied for data storage and/or they are output incorrelation with the identified user.

While the application has been illustrated and described in detail inthe drawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the selected embodiments have been shown and described and that allchanges, modifications and equivalents that come within the spirit ofthe invention as defined herein or by any of the following claims aredesired to be protected.

What is claimed is:
 1. A measurement system for analyte determination,comprising: a display screen; an analysis unit, which is configured todetermine an analyte measured value for a body fluid specimen applied, afingerprint sensor unit, which is configured to detect fingerprintsensor signals for one or various users, and a control unit, which isconnected to the analysis unit and to the fingerprint sensor unit fordata transmission, wherein the control unit is configured to perform auser identification using fingerprint sensor signals detected and toenable a determination of an analyte measured value on successful useridentification using the analysis unit for an identified user, andwherein, in addition to the user identification, the control unit isadditionally configured to perform a finger tissue analysis in asupplementary analysis of the detected fingerprint sensor signals, andto provide control signals for user information as a function thereofthe control signals displaying on the display screen a notification tothe user comprising at least one of a notification that the fingerplaced on the fingerprint sensor unit is not suitable for taking a bloodsample and a notification to the user to take the blood sample fromanother finger based on the finger tissue analysis.
 2. The measurementsystem according to claim 1, wherein the control unit is additionallyconfigured to provide, on successful user identification, analytemeasured values which are determined with the help of the analysis unitfor the body fluid specimen applied, assigned to the identified user forat least one of data storage and output.
 3. The measurement systemaccording to claim 1, wherein the control unit is additionallyconfigured to provide control signals for controlling a user menu in asecond supplementary analysis of the fingerprint sensor signals detectedas a function of the fingerprint sensor signals detected for controllinga user menu and to control the user menu in accordance with the controlsignals.
 4. The measurement system according to claim 3, wherein thecontrol unit is additionally configured to identify a finger of a humanhand in the second supplementary analysis of the detected fingerprintsensor signals and to provide control signals assigned to this finger asa function of the finger identified.
 5. The measurement system accordingto claim 1, further comprising an input unit configured to receive acode key, wherein the control unit is further configured to additionallyanalyze the received code key, to enable the determination of theanalyte measured value and to provide the control signals for executingthe additional measurement system functions.
 6. The measurement systemaccording to claim 1, further comprising an input unit configured toreceive a code key, wherein the control unit is further configured toadditionally analyze the received code key, to enable the determinationof the analyte measured value.
 7. The measurement system according toclaim 1, further comprising an input unit configured to receive a codekey, wherein the control unit is further configured to additionallyanalyze the received code key, to provide the control signals forexecuting the additional measurement system functions.
 8. Themeasurement system according to claim 1, wherein the control unit isadditionally configured to detect scarring of the finger tissue from thefinger tissue analysis, the control signals displaying a notification tothe user based on the detecting of scarring.
 9. The measurement systemaccording to claim 1 in which the notification to the user is to takethe blood sample from another finger.
 10. The measurement systemaccording to claim 9 in which the notification to the user to take theblood sample from another finger is based upon detecting scarring of thefinger tissue.
 11. The measurement system according to claim 1 in whichthe notification to the user is that the finger is not suitable fortaking a blood specimen.
 12. The measurement system according to claim11 in which the notification that the finger is not suitable for takinga blood specimen is based upon detecting scarring of the finger tissue.13. A method for operating a measurement system for analytedetermination, in which a fingerprint sensor unit and an analysis unitequipped for determination of an analyte measured value are connected toa control unit at least for data transmission and a display screen, suchthat the method comprises the following steps: detecting fingerprintsensor signals by means of the fingerprint sensor unit, analyzing thedetected fingerprint sensor signals by means of the control unit toidentify a user, enabling a determination of an analyte measured valuefor a body fluid specimen to be applied with the analysis unit aftersuccessful user identification, and providing control signals forperforming additional measurement systems functions by analyzing thedetected fingerprint sensor signals by means of the control unit inaddition to the user identification, wherein a finger tissue analysis isperformed in a supplementary analysis of the detected fingerprint sensorsignals, and control signals for user information are supplied as afunction thereof, the control signals including displaying on thedisplay screen a notification to the user comprising at least one of anotification that the finger placed on the fingerprint sensor unit isnot suitable for taking a blood sample and a notification to the user totake the blood sample from another finger based on the finger tissueanalysis.
 14. The method according to claim 13, wherein after successfuluser identification, analyte measured values which have previously beendetermined with the help of the analysis unit for a body fluid specimenapplied are supplied for at least one of data storage and output inallocation to the identified user by means of the control unit.
 15. Themethod according to claim 13, wherein control signals are made availablefor controlling a user menu in a second supplementary analysis of thedetected fingerprint sensor signals as a function of the detectedfingerprint sensor signals, and the user menu is controlled according tothe control signals.
 16. The method according to claim 15, wherein oneor more fingers of a human hand are identified in the secondsupplementary analysis of the detected fingerprint sensor signals, andcontrol signals are supplied as a function of the finger or all theidentified fingers.
 17. The method according to claim 13, wherein a codekey is received by an input unit and the control unit additionallyanalyzes the received code key for enabling the determination of theanalyte measured value and providing the control signals for executingthe additional measurement system functions.
 18. The method according toclaim 13, wherein a code key is received by an input unit and thecontrol unit additionally analyzes the received code key for enablingthe determination of the analyte measured value.
 19. The methodaccording to claim 13, wherein a code key is received by an input unitand the control unit additionally analyzes the received code key forproviding the control signals for executing the additional measurementsystem functions.
 20. The method according to claim 13, wherein thesupplementary analysis of the detected fingerprint sensor signals is todetect scarring of the finger tissue from the finger tissue analysis,the control signals displaying a notification to the user based on thedetecting of scarring.
 21. The method according to claim 13 in which theproviding control signals comprises displaying the notification to theuser to take the blood sample from another finger.
 22. The methodaccording to claim 21 in which the displaying the notification to theuser to take the blood sample from another finger is based upondetecting scarring of the finger tissue.
 23. The method according toclaim 13 in which the providing control signals comprises displaying thenotification to the user that the finger is not suitable for taking ablood specimen.
 24. The method according to claim 23 in which thedisplaying the notification to the user that the finger is not suitablefor taking a blood sample is based upon detecting scarring of the fingertissue.